Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Endovascular treatment with investigational device.
Rate of Major Adverse Events (MAEs)
Primary safety endpoint is a composite of the following MAEs occurring through 30 days: * Death * Stroke (excluding transient ischemic attack) * Paralysis (excludes paraparesis)
Time frame: 30 days
Technical success
Primary effectiveness rate as measured by the technical success through 24 hours, defined as: * Successful delivery of the device through the vasculature; * Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.
Time frame: 24 hours
Stent graft patency
Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
Time frame: 12 months
Aneurysm rupture
Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
Time frame: 12 months
Absence of Type I and III endoleak through 12 months;
Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
Time frame: 12 months
Absence of stent fractures in the attachment zone through 12 months
Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
Time frame: 12 months
Absence of open or endovascular secondary interventions
Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
Time frame: 12 months
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University of Alabama-Birmingham
Birmingham, Alabama, United States
Arizona Heart Institute
Phoenix, Arizona, United States
University of California, Irvine
Irvine, California, United States
Long Beach Memorial Hospital
Long Beach, California, United States
Hartford Hospital
Hartford, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University Health
Indianapolis, Indiana, United States
St. Vincent Heart Center
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinic
Iowa City, Iowa, United States
...and 25 more locations
Absence of aneurysm expansion (> 5 mm diameter increase)
Primary effectiveness as measured by the absence of aneurysm expansion (\> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study.
Time frame: 12 months
Absence of stent-graft migration
Primary effectiveness as measured by the absence of stent-graft migration (\> 10 mm) through 12 months, compared to the first post-procedural CT.
Time frame: 12 months
Loss of stent-graft patency
Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.
Time frame: 1 month and 6 months
Rate of aneurysm rupture
The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events.
Time frame: 1 month and 6 months
Rate of endoleaks of all types
Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media.
Time frame: 1 month, 6 months and 12 months
Rate of stent fractures in the attachment zone
Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media.
Time frame: 1 month and 6 months
Incidence of open or endovascular secondary interventions
Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion).
Time frame: 1 month and 6 months
Rate of aneurysm expansion
The rate of aneurysm expansion (\> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT
Time frame: 1 month and 6 months
Rate of stent-graft migration
The rate of stent-graft migration (\> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.
Time frame: 1 month and 6 months
Individual outcomes of composite MAEs
Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss \>1,000 cc.
Time frame: 6 months and 12 months
Rate of vascular access complications
Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system.
Time frame: During the initial implant attempt
Duration of implant procedure
Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.
Time frame: Treatment Visit
Number of blood transfusions
Number of transfusions (units) required from the time of implant through hospital discharge.
Time frame: Treatment Visit through Discharge Visit
Duration of hospitalization
Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.
Time frame: Treatment Visit through Discharge Visit
Time in Intensive Care Unit (ICU)
Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.
Time frame: Treatment Visit through Discharge Visit